Alabama Tavneos Lawyer: Liver Injury and Vanishing Bile Duct Syndrome Claims

We wrote this page for Alabama patients who took Tavneos for ANCA vasculitis and then developed liver trouble: yellow eyes, itching that wouldn’t quit, a hospital stay, a biopsy report that mentioned bile duct loss. It’s also for the families who watched a parent go into the hospital for vasculitis care and never come home.

We’re Fob & Foster Personal Injury Lawyers, a Birmingham firm with an office in Mobile. We are reviewing Tavneos claims from across Alabama now, before any lawsuit has been filed, because Alabama’s deadline and fault rules are among the least forgiving in the country.

What Happened to Tavneos in 2026

The FDA approved Tavneos on October 7, 2021, as an add-on treatment for adults with severe active ANCA-associated vasculitis, used with standard therapy that includes steroids. Amgen completed its roughly $3.7 billion purchase of the maker, ChemoCentryx, on October 20, 2022. Amgen says more than 8,000 U.S. patients have been treated. For four years it was a quiet specialty drug. In 2026, regulators on three continents turned on it.

January: The FDA Asks Amgen to Pull It

On January 16, 2026, the FDA’s Center for Drug Evaluation and Research (CDER) asked Amgen to voluntarily withdraw Tavneos. Amgen declined on January 28.

March 31: The Liver Injury Safety Communication

The FDA’s Drug Safety Communication on serious liver injury in Tavneos patients reported:

• 76 cases of drug-induced liver injury (DILI) with reasonable evidence of a causal link to Tavneos, 74 of them serious, including 54 hospitalizations and 8 deaths.
• 7 biopsy-confirmed cases of vanishing bile duct syndrome (VBDS). All 7 patients were hospitalized and 3 died.
• A median onset of 46 days after starting the drug (range 22 to 140 days).
• Among 60 cases with lab data, 38 showed a cholestatic or mixed pattern, meaning bile flow was involved.
• Reports from Japan (66), the U.S. (5), Europe (4) and Canada (1).

April 27: The Proposal to Withdraw Approval

CDER then proposed withdrawing approval of Tavneos and offered Amgen a hearing (Federal Register, April 30, 2026; Docket FDA-2026-N-1321). The legal grounds were a lack of substantial evidence of effectiveness and untrue statements of material fact in the application. The liver cases appear as background “new safety concerns,” not as the legal basis.

May Through September: Japan, Europe, Canada and the UK

On May 15, 2026, Kissei reported 20 fatal cases of serious liver injury among about 8,500 patients in Japan; Japan’s regulator later said a causal link to the drug could not be ruled out in 2 of them. It ordered an urgent label revision on May 21 and then allowed new patients to start again under the stricter label. That same month the U.S. label’s hepatotoxicity warning was strengthened to describe VBDS, including fatal cases. Health Canada advised on July 7 against starting new patients. The European Commission revoked the EU authorization on August 4, following an EMA committee recommendation on June 25. The UK’s MHRA stopped new-patient supply on September 1 and said the pivotal study “can no longer be relied upon.”

Where Things Stand Today

Amgen requested a hearing on June 1 and filed data on July 23. The FDA has announced no decision. Tavneos stays on the U.S. market until Amgen removes it or the FDA Commissioner orders withdrawal, and the FDA has told doctors to discuss with patients whether to start or continue it.

What Tavneos Treats and How Alabama Patients Get It

ANCA-associated vasculitis is a rare autoimmune disease that inflames small blood vessels, often in the kidneys, lungs and sinuses. Tavneos is approved for its two main forms, granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). The usual dose is three 10 mg capsules twice a day with food.

Most prescriptions come from rheumatologists and nephrologists. In Alabama, many vasculitis patients are treated by specialists at UAB in Birmingham, and others by rheumatology and kidney practices in Huntsville, Mobile, Montgomery and Tuscaloosa. Severe liver cases are commonly referred to a hepatologist, and a transplant evaluation in this state usually means a trip to Birmingham. We name these places only because that’s where a Tavneos patient’s records tend to sit.

You can’t fill Tavneos at a neighborhood pharmacy. It’s dispensed only through select specialty pharmacies (currently PANTHERx Rare and Biologics), with enrollment through Amgen’s “TAVNEOS Connect” hub, which handles start forms, copay programs and home shipping. That paper trail is some of the best proof of use in these cases.

Most patients are older adults also taking steroids, rituximab or cyclophosphamide, and other liver-toxic drugs may be in the picture. The defense will point at them. We’d rather you hear that from us first.

How Tavneos Can Injure the Liver

Vanishing Bile Duct Syndrome in Plain Terms

Your liver drains bile through tiny ducts inside the organ. In VBDS, those small ducts are progressively destroyed and disappear, and bile backs up into the liver and bloodstream (cholestasis). MedlinePlus, the National Library of Medicine’s patient reference, lists the symptoms of cholestasis: yellow skin or eyes, itching, dark urine, pale or clay-colored stools, nausea or vomiting and pain in the upper right abdomen.

How Doctors Confirm It

Blood tests come first: bilirubin, alkaline phosphatase (ALP), GGT, ALT and AST. An ultrasound or MRCP rules out a blockage such as a gallstone. A liver biopsy is the gold standard, because only tissue shows whether the ducts are gone. If you had a biopsy, that pathology report may be the most important page in your file.

Why Stopping the Drug May Not End the Damage

VBDS can keep progressing after the medicine is stopped. Some patients recover; others develop chronic liver disease, need a transplant, or die. NIH Drug-Induced Liver Injury Network data found that bile duct loss on biopsy predicted worse outcomes and chronic injury in most patients. A Tavneos claim has to account for future care, not just the hospital bill.

Warning Signs and When to Get Medical Care

The FDA told patients to contact a health care professional right away for signs of liver injury, including unusual tiredness, nausea, vomiting, unusual itching, light-colored stools, yellowing of the skin or eyes, dark urine, abdominal swelling, or pain in the upper right abdomen. For doctors, it advised liver tests every two weeks in the first month and then monthly for five months, and stopping the drug promptly if ALT or AST rises above three times the upper limit of normal, ALP above twice the upper limit, or the patient develops jaundice or itching from cholestasis.

Do not stop or change a prescription without talking to your doctor. Uncontrolled vasculitis can damage the kidneys and lungs. That decision belongs to you and your physician, and nothing here is medical advice.

Why the Trial-Data Findings Matter to a Liver Injury Case

The FDA’s withdrawal case is about trial data, and people ask what that has to do with their liver. Quite a lot.

According to CDER, the first database lock of the pivotal ADVOCATE trial on November 5, 2019, showed the primary endpoint was not statistically significant (p=0.1025). CDER says unblinded company personnel then selected subjects for readjudication, producing a second lock on November 20, 2019 (p=0.0132), and the application did not disclose the original analysis. The New England Journal of Medicine retracted the 2021 ADVOCATE paper on June 29, 2026. Amgen disputes the FDA, and the Duke Clinical Research Institute re-review it submitted found Tavneos non-inferior, but not superior, to the steroid comparator.

A product liability case asks whether a drug’s benefit justified its risk and whether the company told doctors what it knew. If the advantage over steroids was smaller than the approval suggested, the liver risk weighs heavier. In the pivotal trial, hepatic adverse reactions occurred in 13.3% of Tavneos patients versus 11.6% on prednisone (serious: 5.4% versus 3.7%). Hepatotoxicity has been in the label’s Warnings and Precautions since approval, so the question is whether that warning said enough, soon enough.

Then there’s timing. Amgen has stated that it proposed a VBDS label update in April 2024, about two years before the U.S. label described VBDS deaths. What Amgen knew and what it told Alabama prescribers in between goes to failure to warn, and potentially to wantonness and punitive damages.

Who May Have a Tavneos Claim in Alabama

We’re evaluating cases where someone took Tavneos in Alabama and then had:

• Jaundice or cholestasis diagnosed after starting the drug
• A hospital admission for liver injury
• Vanishing bile duct syndrome, especially biopsy-confirmed
• Acute or chronic liver failure
• A liver transplant referral or transplant
• A death in which liver injury played a part

The FDA’s 22-to-140-day onset window is a useful benchmark. An injury outside it isn’t ruled out, but it needs a closer look.

The harder cases deserve candor. If your enzymes rose, your doctor stopped the drug, and you were normal within weeks with no hospital stay, a lawsuit may not make sense, and we’ll say so. Several liver-toxic medicines at once make causation harder but not impossible. And the defense will stress that most reports came from Japan.

Alabama’s Contributory Negligence Rule and Missed Liver Monitoring

Alabama is one of the few states that still follows contributory negligence. Elsewhere, partial fault reduces an award. Here, a defendant can argue that any negligence by the injured person that contributed to the harm bars recovery entirely. We expect Amgen to lean on this in Alabama, and we plan for it from the first call.

How the Defense Will Frame It

The label called for liver tests. The patient missed a lab draw, or kept taking capsules after the itching started, or waited until the next appointment to mention dark urine. So, the argument goes, the patient’s own carelessness caused the injury.

How We Answer It

• Which label applied. We start with the label in force on the date of your prescription, not the May 2026 version. The earlier label called for liver tests before starting and every four weeks for six months, but it did not mention vanishing bile duct syndrome or fatal cases, so neither you nor your doctor was told what a missed sign could mean.
• Who orders the tests. Under the learned intermediary doctrine, Amgen’s warning duty ran to your prescriber, and lab orders come from the doctor’s office. A patient who kept the appointments she was given stands on solid ground.
• What you actually knew. Alabama generally requires the defense to show the injured person knew and appreciated the specific danger. Few patients were told their bile ducts could disappear, and tiredness and nausea overlap with vasculitis and steroid side effects.
• Wantonness. Contributory negligence is generally not a defense to a wantonness claim under Alabama law.

Alabama’s Two-Year Deadline for Tavneos Claims

Alabama allows two years to file most personal injury claims, Ala. Code § 6-2-38(l). The fight is over when those two years began. Alabama courts generally start the clock when the injury occurred or first manifested, and they apply discovery-type extensions far less generously than most states. A defense lawyer may say your clock started with the first abnormal liver panel, the first visible jaundice, or the first admission.

The FDA’s March 31, 2026 announcement generally does not start or restart it. With a median onset of 46 days, a patient whose liver injury began before late October 2024 may already be past the two-year line, and one injured in late 2024 or 2025 may be close to it.

Please don’t calculate your deadline from this page. Call us with your start date and the date of your first liver symptoms, and we’ll give you a straight answer.

Alabama Product Liability Law for a Tavneos Case

An Alabama drug injury case usually pleads several theories together:

• The Alabama Extended Manufacturer’s Liability Doctrine (AEMLD): whether the drug was unreasonably dangerous when it left the manufacturer.
• Failure to warn: whether the label adequately warned prescribers of the liver risk, including VBDS, when you were prescribed.
• Negligence: whether Amgen acted as a reasonable drug maker in testing, tracking safety reports and updating the label.
• Wantonness: whether it consciously disregarded a known risk.

Because the learned intermediary doctrine applies, a central question is what your rheumatologist or nephrologist would have done with a stronger warning. That’s not an accusation against your doctor; in most of these cases the doctor relied on the label like everyone else. Alabama does not cap compensatory damages, and punitive damages require clear and convincing evidence under Ala. Code § 6-11-20.

When a Tavneos Liver Injury Was Fatal: Alabama Wrongful Death for Families

Alabama’s wrongful death statute, Ala. Code § 6-5-410, surprises most families. Damages are punitive only. They exist to punish and deter, so the jury looks at the defendant’s conduct, not at the person’s earnings, the family’s grief, or a dollar value on the life. For a Tavneos death, the case becomes a case about what Amgen knew and did: the trial data, the April 2024 label proposal Amgen describes, and the timing of the warnings.

Only the personal representative of the estate can file, and the suit must be brought within two years of the death. If no estate has been opened, the family generally has to start that in probate court first, which takes time. Keep the death certificate, any autopsy report and the final hospital records.

Records That Prove a Tavneos Case, Sorted by Who Holds Them

You don’t need all of this before calling us; with your authorization we can request most of it. Sorting by holder tells you who to ask.

Specialty Pharmacy (PANTHERx Rare or Biologics)

• Dispensing and shipment history with dates, plus any notes showing when the drug was stopped

Amgen’s TAVNEOS Connect Hub

• Your enrollment and start form
• Copay program or copay card records

Your Health Insurer or Medicare Plan

• The Tavneos prior authorization and pharmacy and medical claims from the treatment period

Your Rheumatologist or Nephrologist

• Notes from the visit when Tavneos was started
• Lab orders and liver panel results
• Monitoring instructions or handouts you were given
• A full medication list for the period

Hospital, Hepatologist or Transplant Center

• Liver tests over time (bilirubin, ALP, GGT, ALT, AST)
• Ultrasound or MRCP reports and the biopsy pathology report
• Admission and discharge summaries, hepatology consults and any transplant evaluation

At Home

• Capsule bottles, cartons and shipping labels
• Notes or calendar entries showing when symptoms began, and photos of jaundice
• Receipts and records of missed work

What a Tavneos Claim May Be Worth

No Tavneos injury case has been reported filed, tried or settled. There are no settlement figures, and anyone quoting a number is guessing. What drives value:

• Severity: resolved lab changes, a hospital stay, biopsy-confirmed VBDS, chronic disease and a transplant are very different cases.
• Future care: hepatology follow-up, imaging, itching treatment, possible transplant.
• Lost income, yours or a spouse’s who became a caregiver.
• Pain, itching and fatigue, which in cholestatic disease can last.
• Causation strength: onset timing and the other drugs involved.
• Amgen’s conduct, which drives punitive damages and is the whole measure in an Alabama death case.
• Contributory negligence risk on your facts.

No Tavneos Injury Lawsuit Has Been Reported Yet. That Doesn’t Buy You Time.

As of October 20, 2026, no Tavneos personal injury lawsuit, MDL or JPML petition has been reported, and firms nationally are investigating. That’s normal this soon after an FDA safety communication. Your Alabama deadline, though, runs from your injury, not from the first filing somewhere else. If cases are filed next year and an MDL follows, an Alabama patient whose two years ran out in the meantime may be shut out.

The “class action” in the headlines is Homyk v. ChemoCentryx, an investor securities case in the Northern District of California with a proposed $69 million settlement (revised stipulation dated May 15, 2026) that still needs final court approval. The final approval hearing is scheduled for October 29, 2026. It does nothing for patients.

What to Do This Week

1. Get medical care now for jaundice, dark urine, upper right abdominal pain or unusual tiredness, and don’t stop or change Tavneos without your prescriber.
2. Write down four dates: when you started Tavneos, when symptoms began, your first abnormal liver test, and when you were admitted or the drug was stopped.
3. Keep every bottle, carton and shipping label.
4. Download lab results, the biopsy report and discharge summaries from your patient portals.
5. List every medication you took during the Tavneos period.
6. Keep your health off social media while a claim is evaluated.
7. Call (205) 407-6009 for a deadline check, with the dates from step 2.

Meeting With Us in Birmingham or Mobile, or by Phone

Our office is at 2226 1st Ave S, Suite 105, Birmingham, AL 35233, and our Mobile office is at 411 St. Francis Street, Mobile, AL 36602. Liver patients are often too worn out to travel, so most first reviews happen by phone or video. If you searched for a Tavneos lawyer near me from Huntsville, Decatur, Auburn or Dothan, you don’t need to drive anywhere; we review claims from every part of Alabama, and adult children are welcome to do the talking. We work alongside national co-counsel who litigate pharmaceutical mass torts, so if a federal proceeding forms, your case may be able to join it while your lawyer stays here at home.

Tavneos Lawsuit Timeline

October 20, 2026 – No FDA Decision, No Injury Suits Reported

Tavneos remains on the U.S. market. The investor settlement’s final approval hearing is scheduled for October 29.

September 1, 2026 – UK Halts New-Patient Supply

MHRA says it intends to revoke the UK license on March 1, 2027. The UK product is now sold as Avacopan Vifor.

August 4, 2026 – European Commission Revokes Authorization

Follows the EMA committee’s June 25 recommendation, which told doctors not to start new patients.

July 23, 2026 – Amgen Files Hearing Data

Includes the Duke re-review. Amgen has separately said there have been “no known deaths in the U.S.” linked to serious liver injury.

July 7, 2026 – Health Canada Advisory

No new patients during a data-integrity review.

June 25, 2026 – EMA Committee Recommends Revocation

NEJM retracted the 2021 ADVOCATE paper four days later, on June 29.

June 1, 2026 – Amgen Requests a Hearing

May 21, 2026 – Japan Orders Urgent Label Revision

After Kissei’s May 15 report of 20 fatal cases. The U.S. label’s liver warning was strengthened the same month.

April 27, 2026 – CDER Proposes Withdrawing Approval

Docket FDA-2026-N-1321.

March 31, 2026 – FDA Drug Safety Communication

76 liver injury cases, 8 deaths, 7 biopsy-confirmed VBDS cases.

January 28, 2026 – Amgen Refuses Voluntary Withdrawal

Response to CDER’s January 16 request.

April 2024 – Amgen Says It Proposed a VBDS Label Update

October 20, 2022 – Amgen Completes ChemoCentryx Purchase

October 7, 2021 – FDA Approves Tavneos

NDA 214487, for severe active ANCA-associated vasculitis.

Talk to an Alabama Tavneos Lawyer Today

Fob & Foster Personal Injury Lawyers is a Birmingham personal injury firm with a second office in Mobile. We’re reviewing Tavneos liver injury and vanishing bile duct syndrome claims for patients and families from Birmingham and Hoover to Huntsville, Montgomery, Mobile, Tuscaloosa and Dothan.

The free review is a conversation. We’ll ask when you started Tavneos, when the liver problems began and who has your records, then tell you whether we see a claim and where your Alabama deadline likely stands. There’s no fee unless we recover.

Call (205) 407-6009 or toll-free (866) 837-1010, or send us your question online. Under Alabama’s two-year rule, the sooner we see your dates, the more options you keep.

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